The trial tested those who underwent hernia repair surgery. The trial results indicate that LidoPAIN did not achieve a statistically significant effect relative to placebo with respect to the primary endpoint.
The company's initial analysis of the trial data indicates that the total amount of pain from 4-24 hours as measured by the area under the curve had a p value of approximately 0.4; the co-primary endpoint of rescue medication use from hours 4-24 had a p value of approximately 0.09. Both treatment groups showed an analgesic effect with the greater analgesic response in the active group. The product was well tolerated in all treatment groups.
“We are obviously disappointed that LidoPAIN did not meet its co-primary endpoints, particularly in light of the positive results achieved by the product candidate in its Phase II trial. We will in particular be looking at changes which occurred in going from Phase II to Phase III. A thorough analysis of the trial results has been initiated and our findings will serve as the basis for our decision on next steps for this product candidate,” stated Jack Talley, President and Chief Executive Officer of EpiCept.